Use in Pregnancy: Pregnancy Category C: Increased incidences of fetal structural abnormalities and other manifestations of developmental toxicity, including lethality, growth retardation, and nervosa and reproductive system functional impairment, were observed in the offspring of rats and rabbits given pregabalin during pregnancy at dose that produced plasma pregabalin exposures (AUC) at least 5 times human exposure at the maximum recommended human dose of 600 mg/day.
There are no adequate and well-controlled studies in pregabalin woman. It is not known if pregabalin crosses the human placenta. The low molecular weight (approximately 159), minimal metabolism, lack of plasma protein binding, and the moderately long elimination half-life suggest that the drug will reach the embryo and fetus. Use pregabalin during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Labor and delivery: The effects of pregabalin on labor and delivery in pregnant woman are unknown. In the prenatal-postnatal study in rats, pregabalin prolonged gestation and induced dystocia at exposures of 50 times or more the mean human exposure (AUC(0-24) of 123 mcg*h/mL) at the maximum recommended clinical dosage of 600 mg/day.
Use in Lactation: It is not known if pregabalin is excreted in human milk; it is, however, present in the milk of rats. The low molecular weight (approximately 159), minimal metabolism, lack of plasma protein binding, and the moderately long elimination half-life (6 hours) suggest that the drug will also be excreted into breast milk. Because it is freely soluble in water, the highest concentrations of the drug are found in foremilk. Because many drugs are excreted into human milk and because of the potential for tumorigenicity shown for pregabalin in animal studies, decide whether to discontinuous breast-feeding or the drug, taking into account the importance of the drug to the mother.